通淋胶囊质量标准的研究

Studies on the quality standard of Tonglin capsule

目的：研究中药制剂通淋胶囊的质量标准。方法：采用ＴＬＣ对白术、丹皮、黄柏、甘草等成分进行色谱鉴别，薄层荧光扫描法测定盐酸小檗碱的含量。结果：鉴别方法专属性强。含量测定盐酸小檗碱在０．０５１６μｇ～０．３０９６μｇ间有良好的线性关系，回收率为９７．３１％，ＲＳＤ为２．６５％。

OBJECTIVE:To study the quality standard of Tonnglin capsule.METHOD:Thin layer chromatography was used for simultaneously identification Rhizoma atractylodis macrocephalae,Cortex moutan, Cortex phellodendri and Radix glycyrrhizae. TLC fluorescence scanning was used for the determination of berberine chloride.RESULTS:The TLC identification was highly specific and the spots were clear and concentrated.Linear regression for borberine chloride was over the range of 0.0516 μg～0.3096 μg.The average recovery of berberine chloride was 97.31%,RSD was 2.65%.CONCLUSION:This standard was capable to effectively control the quality of Tonglin capsule.